57954 Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Notices 

dangerous crossings, ropes, or boats to 

ferry goods and people across 

waterways. 

Parties: 

Principal Supplier: Acrow 

Corporation of America. 

Obligor: Ministry of Finance of the 

Republic of Angola. 

Guarantor(s): None. 

Description of Items Being Exported: 

186 modular steel panel bridges and 

ancillary bridging equipment, as well as 

technical training and advisory services. 

Information on Decision: Information 

on the final decision for this transaction 

will be available in the ‘‘Summary 

Minutes of Meetings of Board of 

Directors’’ on http://exim.gov/ 

newsandevents/boardmeetings/board/. 

Confidential Information: Please note 

that this notice does not include 

confidential or proprietary business 

information; information which, if 

disclosed, would violate the Trade 

Secrets Act; or information which 

would jeopardize jobs in the United 

States by supplying information that 

competitors could use to compete with 

companies in the United States. 

Authority: Section 3(c)(10) of the 

Export-Import Bank Act of 1945, as 

amended (12 U.S.C. 635a(c)(10)). 

Joyce B. Stone, 

Assistant Corporate Secretary. 

[FR Doc. 2023–18249 Filed 8–23–23; 8:45 am] 

BILLING CODE 6690–01–P 

FEDERAL RESERVE SYSTEM 

Formations of, Acquisitions by, and 

Mergers of Bank Holding Companies 

The companies listed in this notice 

have applied to the Board for approval, 

pursuant to the Bank Holding Company 

Act of 1956 (12 U.S.C. 1841 et seq.) 

(BHC Act), Regulation Y (12 CFR part 

225), and all other applicable statutes 

and regulations to become a bank 

holding company and/or to acquire the 

assets or the ownership of, control of, or 

the power to vote shares of a bank or 

bank holding company and all of the 

banks and nonbanking companies 

owned by the bank holding company, 

including the companies listed below. 

The public portions of the 

applications listed below, as well as 

other related filings required by the 

Board, if any, are available for 

immediate inspection at the Federal 

Reserve Bank(s) indicated below and at 

the offices of the Board of Governors. 

This information may also be obtained 

on an expedited basis, upon request, by 

contacting the appropriate Federal 

Reserve Bank and from the Board’s 

Freedom of Information Office at 

https://www.federalreserve.gov/foia/ 

request.htm. Interested persons may 

express their views in writing on the 

standards enumerated in the BHC Act 

(12 U.S.C. 1842(c)). 

Comments regarding each of these 

applications must be received at the 

Reserve Bank indicated or the offices of 

the Board of Governors, Ann E. 

Misback, Secretary of the Board, 20th 

Street and Constitution Avenue NW, 

Washington, DC 20551–0001, not later 

than September 25, 2023. 

A. Federal Reserve Bank of New York 

(Ivan J. Hurwitz, Head of Bank 

Applications) 33 Liberty Street, New 

York, New York 10045–0001. Comments 

can also be electronically sent to 

comments.applications@ny.frb.org: 

1. Helios Bancorp Inc.; to become a 

bank holding company by acquiring 

Alpine Capital Bank, both of New York, 

New York. 

Board of Governors of the Federal Reserve 

System. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2023–18223 Filed 8–23–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: 

‘‘Consumer Assessment of Healthcare 

Providers and Systems (CAHPS) Health 

Plan Survey Database.’’ In accordance 

with the Paperwork Reduction Act of 

1995, AHRQ invites the public to 

comment on this proposed information 

collection. 

DATES: Comments on this notice must be 

received by October 23, 2023. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Consumer Assessment of Healthcare 

Providers and Systems (CAHPS) Health 

Plan Survey Database 

AHRQ requests that OMB reapprove 

AHRQ’s collection of information for 

the AHRQ Consumer Assessment of 

Healthcare Providers and Systems 

(CAHPS) Health Plan Survey Database: 

OMB Control number 0935–0165, 

expiration November 30, 2023 (the 

CAHPS Health Plan Database). The 

CAHPS Health Plan Database consists of 

data from the AHRQ CAHPS Health 

Plan Survey. Health plans in the U.S. 

are asked to voluntarily submit data 

from the survey to AHRQ, through its 

contractor, Westat. The CAHPS Health 

Plan Database was developed by AHRQ 

in 1998 in response to requests from 

health plans, purchasers, and the 

Centers for Medicare & Medicaid 

Services (CMS) to provide comparative 

data to support public reporting of 

health plan ratings, health plan 

accreditation and quality improvement. 

This research has the following goals: 

(1) To maintain the CAHPS Health 

Plan Database using data from AHRQ’s 

standardized CAHPS Health Plan 

Survey to provide results to health care 

purchasers, consumers, regulators and 

policy makers across the country. 

(2) To offer several products and 

services, including aggregated results 

presented through an Online Reporting 

System, summary chartbooks, custom 

analyses, and data for research 

purposes. 

(3) To provide data for AHRQ’s 

annual National Healthcare Quality and 

Disparities Report. 

(4) To provide state-level data to CMS 

for public reporting on Medicaid.gov 

and Data.Medicaid.gov that does not 

display the name of the health plans. 

Survey data from the CAHPS Health 

Plan Database is used to produce four 

types of products: (1) An annual 

chartbook available to the public on the 

CAHPS Database website (https://

www.ahrq.gov/sites/default/files/ 

wysiwyg/cahps/cahps-database/2022- 

hp-chartbook.pdf)); (2) individual 

participant reports that are confidential 

and customized for each participating 

organization (e.g., health plan, Medicaid 

agency) that submits their data; (3) a 

research database available to 

researchers wanting to conduct 

additional analyses; and (4) data tables 

provided to AHRQ for inclusion in the 

National Healthcare Quality and 

Disparities Reports. 

This study is being conducted by 

AHRQ through its contractor, Westat, 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Notices 57955 

pursuant to AHRQ’s statutory authority 

to conduct and support research on 

healthcare and on systems for the 

delivery of such care, including 

activities with respect to the quality, 

effectiveness, efficiency, 

appropriateness and value of healthcare 

services; quality measurement and 

development, and database 

development. 42 U.S.C. 299a(a)(1), (2) 

and (8). 

Method of Collection 

To achieve the goals of this project the 

following activities and data collections 

will be implemented: 

• Registration Form—The point-ofcontact (POC), often the sponsor from 

Medicaid agencies and health plans, 

completes a number of data submission 

steps and forms, beginning with the 

completion of the online registration 

form. The purpose of this form is to 

collect basic contact information about 

the organization and initiate the 

registration process. 

• Health Plan Information Form—The 

purpose of this form, completed by the 

participating sponsor organization, is to 

collect background characteristics of the 

health plan. 

• Data Use Agreement—The purpose 

of the data use agreement, completed by 

the participating sponsor organization, 

is to state how data submitted by health 

plans will be used and provide 

confidentiality assurances. 

• Data Files Submission—POCs 

upload their data file using the Health 

Plan data file specifications to ensure 

that users submit standardized and 

consistent data in the way variables are 

named, coded, and formatted. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated burden 

hours for the respondent to participate 

in the database. The burden hours 

pertain only to the collection of 

Medicaid data from State Medicaid 

agencies and individual Medicaid 

health plans because those are the only 

entities that submit data through the 

data submission process. The 125 POCs 

in Exhibit 1 are a combination of an 

estimated 115 State Medicaid agencies 

and individual health plans (Sponsors), 

and 10 vendor organizations. 

Each sponsor, which is made up of 

State Medicaid agencies and individual 

health plans, and vendor will register 

online for submission. The online 

Registration form will require about 5 

minutes to complete. Each sponsor will 

also complete a Health Plan information 

form of information about each Health 

Plan such as the name of the plan, the 

product type (e.g., HMO, PPO), the 

population surveyed (e.g., adult 

Medicaid or child Medicaid). Each year, 

the prior year’s plan data are preloaded 

in the plan table to lessen burden on the 

Sponsor. The Sponsor is responsible for 

updating the plan table to reflect the 

current year’s plan information. The 

online Health Plan Information form 

takes on average 30 minutes to complete 

per health plan with each POC 

completing the form for four plans on 

average. The Data Use Agreement (DUA) 

will be completed by the 115 

participating State Medicaid agencies or 

individual health plans. Vendors do not 

sign or submit DUAs. The DUA requires 

about 5 minutes to sign and upload. 

Each submitter will provide a copy of 

their questionnaire and the survey data 

file in the required file format. Survey 

data files must conform to the data file 

layout specifications provided by the 

CAHPS Database. Submitters will 

upload one data file per health plan. 

Once a data file is uploaded the file will 

be checked automatically to ensure it 

conforms to the specifications and a 

data file status report will be produced 

and made available to the submitter. 

Submitters will review each report and 

will be expected to fix any errors in 

their data file and resubmit if necessary. 

It will take about 1 hour to submit the 

data for each plan, and each POC will 

submit data for four plans on average. 

The total burden is estimated to be 710 

hours annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name 

Number of 

respondents/ 

POCs 

Number of 

responses 

per POC 

Hours per 

response 

Total burden 

hours 

Registration Form ............................................................................................ 125 1 5/60 10 

Health Plan Information Form ......................................................................... 115 4 30/60 230 

Data Use Agreement ....................................................................................... 115 1 5/60 10 

Data Files Submission ..................................................................................... 115 4 1 460 

Total .......................................................................................................... 470 NA NA 710 

Exhibit 2 shows the estimated 

annualized cost burden based on the 

respondents’ time to complete one 

submission process. The cost burden is 

estimated to be $36,222 annually. 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Registration Form ............................................................................................ 125 10 a 57.61 $576 

Health Plan Information Form ......................................................................... 115 230 a 57.61 13,250 

Data Use Agreement ....................................................................................... 115 10 b 102.41 1,024 

Data Files Submission ..................................................................................... 115 460 c 46.46 21,372 

Total .......................................................................................................... 470 710 NA 36,222 

* National Compensation Survey: Occupational wages in the United States May 2021, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ aBased on the mean hourly wage for Medical and Health Services Managers (11–9111). 

bBased on the mean hourly wage for Chief Executives (11–1011). 

cBased on the mean hourly wages for Computer Programmers (15–1251). 


lotter on DSK11XQN23PROD with NOTICES1
57956 Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Notices 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3520, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ’s health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: August 21, 2023. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2023–18221 Filed 8–23–23; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0588] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice for Blood and 

Blood Components and Reducing the 

Risk of Transfusion-Transmitted 

Infections 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by September 

25, 2023. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0116. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Current Good Manufacturing Practice 

for Blood and Blood Components and 

Reducing the Risk of TransfusionTransmitted Infections 

OMB Control Number 0910–0116— 

Revision 

This information collection helps 

support FDA implementation of 

statutory and regulatory requirements 

that govern current good manufacturing 

practice (CGMP) for blood and blood 

components. We have issued 

regulations in parts 606, 610, 630, and 

640 (21 CFR parts 606, 610, 630, and 

640) setting forth applicable standards 

and procedures that include associated 

reporting, recordkeeping, and disclosure 

requirements. Respondents to the 

collection of information are licensed 

and registered-only establishments that 

collect blood and blood components 

intended for transfusion or further 

manufacturing use. We provide 

information on our website at https://

www.fda.gov/vaccines-blood-biologics/ 

blood-blood-products regarding CGMP 

for blood and blood products, including 

available Agency resources. 

We are revising the information 

collection to support implementation of 

annual reporting to FDA of the release 

of unsuitable blood donations from 

establishments that intend for their 

activities to fall under the compliance 

policy set forth in the draft guidance for 

industry entitled ‘‘Compliance Policy 

Regarding Blood and Blood Component 

Donation Suitability, Donor Eligibility 

and Source Plasma Quarantine Hold 

Requirements’’ (May 2022). The draft 

guidance describes FDA’s compliance 

policy for certain regulations. Blood 

establishments that collect blood and 

blood components, including Source 

Plasma, must comply with requirements 

in § 630.30 regarding donation 

suitability. However, the draft guidance 

explains the conditions under which 

FDA does not intend to take regulatory 

action for a blood establishment’s 

failure to comply with this requirement 

and describes proposed procedures for 

such an establishment’s filing of annual 

reports on the release of unsuitable 

donations to FDA. Specifically, under 

this policy, when finalized, when the 

donation is otherwise suitable under 

§ 630.30(a), FDA does not intend to take 

regulatory action if blood 

establishments release donations for 

transfusion or further manufacture 

when the review of records, required 

after donation under § 630.30(a)(2), 

identifies the donation as unsuitable 

because of inadvertent failure to follow 

procedures to ensure that the donation 

would not adversely affect the health of 

the donor, namely for: 

• blood pressure (§ 630.10(f)(2)); 

• pulse (§ 630.10(f)(4)); 

• weight (§ 630.10(f)(5)); 

• donation frequency for Whole 

Blood and Red Blood Cells collected by 

apheresis (§ 630.15(a)(1)); 

• pregnancy (§ 630.10(e)(2)(v)); and 

• red blood cell loss for plasma 

collected by plasmapheresis 

(§ 630.15(b)(6)). 

The draft guidance sets forth that FDA 

intends to apply the compliance policy 

provided blood establishments that elect 

to release unsuitable units as described 

in the guidance report the release of 

unsuitable donations to FDA annually. 

The draft guidance document is 

available for download at https://

www.fda.gov/media/158608/download. 

We issued the guidance document 

consistent with our Good Guidance 

Practice regulations in 21 CFR 10.115, 

which provide for public comment at 

any time. We intend on finalizing the 

guidance document upon OMB 

approval of the attendant information 

collection. When finalized, the guidance 

will supersede the guidance entitled, 

‘‘Alternative Procedures for Blood and 

Blood Components During the COVID– 

19 Public Health Emergency; Guidance 

for Industry,’’ dated April 2020. 

As explained in section III.A of the 

guidance, licensed and registered-only 

blood establishments must maintain 

records as required under § 606.160; 

investigate the error that resulted in the 

collection of an unsuitable donation 

under § 630.30(a)(2); and submit a 

report to FDA annually if they intend 

for their activities to fall under this 


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